Skip to main content
OpenTrials
Completed

NCT Number: NCT00337727

Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)

The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1
  • Karnofsky score of 60 or greater

Exclusion criteria

  • Patient is scheduled to receive any dose of cisplatin
  • Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy
  • Any allergies to study drug or antiemetics
  • Taking CYP3A4 substrates/prohibited medication
  • Significant medical or mental conditions
  • Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine).

Treatment and study plan

Aprepitant

Drug

aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.

Other names: MK0869

Comparator: ondansetron

Drug

Ondansetron 8 mg capsule Three day treatment period.

Other names: Zofran®

Comparator: dexamethasone

Drug

dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.

Other names: DEXAMETHASONE TABLETS USP

Comparator: fosaprepitant dimeglumine

Drug

fosaprepitant dimeglumine 115 mg

Other names: EMEND®

Comparator; Placebo (unspecified)

Drug

dexamethasone 12mg Pbo tablets.

Primary outcomes

  1. Number of Patients Who Reported No Vomiting

    Time frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1.

    The number of patients who reported No Vomiting in the overall phase in Cycle

    1

Secondary outcomes

  1. Number of Patients Who Reported Complete Response

    Time frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1

    The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 16, 2006
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.